The use of cordarone for atrial fibrillation. Medicinal reference book geotar

Instructions for use:

Cordarone is an antiarrhythmic drug.

Release form and composition

Dosage forms:

• Dividable tablets: from white with a creamy tint to white, round in shape with a chamfer on both sides, a bevel from the edges to the break line on one side and engraving: above the dividing line - a heart-shaped symbol, under the line - the number 200 (10 each pcs in blisters, 3 blisters in a cardboard pack);
• Solution for intravenous (IV) administration: transparent liquid of light yellow color (3 ml in ampoules, 6 pcs in a box).

Active ingredient: amiodarone hydrochloride:

• 1 tablet – 200 mg;
• 1 ml of solution – 50 mg.

Auxiliary components:

• Tablets: corn starch, lactose monohydrate, magnesium stearate, colloidal anhydrous silicon dioxide, povidone K90F;
• Solution: benzyl alcohol, polysorbate 80, water for injection.

Indications for use

The use of Cordarone in tablet form is indicated for the prevention of relapses:

• Supraventricular paroxysmal tachycardia: attacks of recurrent sustained supraventricular paroxysmal tachycardia, recorded in patients with organic heart disease; attacks of recurrent sustained supraventricular paroxysmal tachycardia recorded in patients without organic diseases heart (if antiarrhythmic drugs of other classes are ineffective or their use is contraindicated); attacks of recurrent sustained supraventricular paroxysmal tachycardia recorded in patients with Wolff-Parkinson-White syndrome;
• Ventricular arrhythmias that pose a threat to the patient’s life, including ventricular tachycardia and ventricular fibrillation (with inpatient treatment with careful cardiac monitoring);
• Atrial fibrillation (atrial fibrillation) and atrial flutter.

In addition, tablets are prescribed for the treatment of patients with rhythm disturbances due to impaired left ventricular function and/or coronary heart disease (CHD).

The tablets are taken to prevent sudden arrhythmic death in patients who have recently had a myocardial infarction and have clinical manifestations chronic heart failure or more than 10 ventricular extrasystoles per hour and reduced left ventricular ejection fraction (less than 40%).

The use of the drug in the form of a solution is indicated for the relief of attacks of ventricular paroxysmal tachycardia, supraventricular paroxysmal tachycardia with a high frequency of ventricular contractions (especially in Wolff-Parkinson-White syndrome), persistent and paroxysmal forms of atrial fibrillation (atrial fibrillation) and atrial flutter.

Cordarone injections are also used for cardiac resuscitation in case of cardiac arrest, against the background of ventricular fibrillation, resistant to defibrillation.

Contraindications

Contraindications to the use of tablets and solution:

• Age up to 18 years;
• Atrioventricular (AV) block of II and III degrees, two- and three-fascicle blocks in patients without a pacemaker;
• Sick sinus syndrome (sinoatrial block, sinus bradycardia), except in cases of correction with an artificial pacemaker (pacemaker);
• Concomitant use with drugs that prolong the QT interval and cause the development of paroxysmal tachycardia, including ventricular “pirouette” tachycardia: class IA antiarrhythmic drugs (hydroquinidine, quinidine, procainamide, disopyramide) and class III (bretylium tosylate, ibutilide, dofetilide), sotalol; other non-antiarrhythmic drugs: vincamine, bepridil, phenothiazines (fluphenazine, cyamemazine, chlorpromazine, levomepromazine, trifluoperazine, thioridazine), benzamides (sultopride, amisulpride, sulpride, veraliprid, tiapride), pimozide, butyrophenones (haloperidol, droperidol), sertindole , cisapride, tricyclic antidepressants, azoles, macrolide antibiotics(including spiramycin, erythromycin when administered intravenously), antimalarials (chloroquine, halofantrine, quinine, mefloquine), difemanil methyl sulfate, pentamidine only when administered parenterally, mizolastine, fluoroquinolones, astemizole and terfenadine;
• Hypomagnesemia, hypokalemia;
• Prolongation of the QT interval, including congenital;
• Pregnancy and breastfeeding period;
• Dysfunction thyroid gland(hyperthyroidism, hypothyroidism);
• Hypersensitivity to the components of the drug and to iodine.

Cordarone should be prescribed with caution to patients with first degree AV block, arterial hypotension, severe chronic (III-IV functional class according to the NYHA classification) or decompensated heart failure, liver failure, bronchial asthma, severe respiratory failure and elderly patients.

The tablets should not be taken if you have interstitial lung disease.

Additional contraindications to the use of the solution:

• Severe arterial hypotension, cardiogenic shock, collapse;
• Intraventricular conduction disorders (two- and three-fascicle blockades) in the absence of a permanent pacemaker;
• Heart failure, arterial hypotension, cardiomyopathy or severe respiratory failure - for intravenous bolus administration.

All of these contraindications should not be taken into account when performing cardiac resuscitation in case of cardiac arrest due to ventricular fibrillation, resistant to cardioversion.

The use of amiodarone in pregnant women is possible for ventricular cardiac arrhythmias that pose a threat to the life of the mother, if the expected clinical effect outweighs the potential risk and danger to the fetus.

Directions for use and dosage

• Tablets: orally, before meals, with a small amount of water. The dosage is prescribed by the doctor based on clinical indications and the patient’s condition. The loading dose in a hospital setting is increased, starting with a daily dose of 0.6-0.8 g (up to 1.2 g) divided into several doses, until a total dose of 10 g is reached after 5-8 days of administration; Outpatient saturation up to 10 g is carried out over 10-14 days at a daily dose of 0.6-0.8 g. The maintenance dose should be the minimum effective, selected individually, can range from 0.1 to 0.4 g per day. The average therapeutic single dose is 0.2 g, daily dose is 0.4 g. The maximum single dose is 0.4 g, daily dose is 1.2 g. Tablets can be taken every other day or with a break 2 days a week;
• Solution for injection: intended for intravenous administration to achieve a rapid antiarrhythmic effect or when it is impossible to take the drug orally. In addition to special emergency clinical situations, the solution should be used only in intensive care hospital conditions under constant monitoring of blood pressure and electrocardiogram (ECG). The solution should not be mixed with other agents, administered into the same infusion line, or used undiluted. For dilution, it is necessary to use only a 5% dextrose (glucose) solution; the concentration of the resulting solution should be no less than when diluting 6 ml of the drug in 500 ml of 5% dextrose (glucose). Administration should always be done through a central venous catheter; administration through peripheral veins is allowed for cardiac resuscitation in ventricular fibrillation resistant to cardioversion in the absence of central venous access. In case of severe cardiac arrhythmias, if it is impossible to take the drug orally, intravenous drip administration through a central venous catheter is recommended at the usual loading dose at the rate of 0.005 g per 1 kg of patient weight in 250 ml of a 5% dextrose (glucose) solution. It should be administered over 20-120 minutes, preferably using an electronic pump. It can be administered 2-3 times within 24 hours; adjustment of the rate of administration depends on the clinical effect. Supportive daily dose amiodarone is usually prescribed in the amount of 0.6-0.8 g, an increase to 1.2 g in 250 ml of a 5% dextrose (glucose) solution is allowed. Over the course of 2-3 days of intravenous administration, you should gradually switch to taking the drug orally. Intravenous jet administration during cardiac resuscitation during cardiac arrest due to ventricular fibrillation, resistant to cardioversion, is recommended at a dose of 0.3 g of the drug diluted in 20 ml of a 5% dextrose (glucose) solution. If there is no clinical effect, additional administration of 0.15 g of amiodarone is possible.

Side effects

The use of Cordarone can cause side effects common to each form:

• From the outside respiratory system: very rarely - bronchospasm and/or apnea due to severe respiratory failure, especially bronchial asthma; acute respiratory distress syndrome (sometimes immediately after surgery, sometimes fatal);
• From the outside of cardio-vascular system: often – moderate (dose-dependent) bradycardia; very rarely - severe bradycardia or sinus node arrest (in exceptional cases), more often in patients with sinus node dysfunction and elderly patients;
• From the outside nervous system: very rarely - headache, benign intracranial hypertension.

The use of tablets can cause the following side effects:

• From the cardiovascular system: infrequently - AV block of varying degrees, sinoatrial block (conduction disturbance), the emergence of new or aggravation of existing arrhythmias; frequency unknown – progression of chronic heart failure (during long-term therapy);
• From the respiratory system: often - cases of alveolar or interstitial pneumonitis, bronchiolitis obliterans with pneumonia (sometimes fatal), pleurisy, pulmonary fibrosis, severe shortness of breath or dry cough with worsening symptoms general condition(increased fatigue, weight loss, increased body temperature) or without it; frequency unknown - pulmonary hemorrhage;
• From the outside digestive system: very often - nausea, vomiting, loss of appetite, decreased or loss of taste, a feeling of heaviness in the epigastrium (especially at the beginning of use, it goes away after reducing the dose), isolated spasmodic disturbance of the activity of liver enzymes in the blood serum; often - jaundice, acute liver damage, liver failure (sometimes fatal); very rarely - chronic liver diseases such as cirrhosis, pseudoalcoholic hepatitis (sometimes fatal);
• From the senses: very often - transient visual impairment (blurred contours in bright light) caused by the deposition of complex lipids in the corneal epithelium; very rarely - neuritis optic nerve or optic neuropathy;
• From the skin: very often – photosensitivity; often – transient skin pigmentation (with long-term therapy); very rarely - erythema, skin rash, alopecia, exfoliative dermatitis (relationship with the drug has not been confirmed);
• From the nervous system: often - extrapyramidal symptoms (tremor), sleep disturbances, nightmares; rarely – myopathy and/or peripheral neuropathies (sensorimotor, mixed, motor); very rarely - cerebellar ataxia;
• Endocrine disorders: often – hypothyroidism (with high level thyroid-stimulating hormone (TSH) serum levels, the drug must be discontinued), hyperthyroidism; very rarely - syndrome of impaired secretion of antidiuretic hormone;
• Other: very rarely - epididymitis, vasculitis, impotence (no connection with amiodarone has been confirmed), hemolytic anemia, thrombocytopenia, aplastic anemia.

The use of Cordarone in the form of a solution causes undesirable effects:

• From the cardiovascular system: often – moderate and transient decrease in blood pressure (BP); very rarely - proarrhythmogenic effect, progression of heart failure, flushing of the face (with intravenous jet administration);
• Violations by immune system: very rarely - anaphylactic shock; frequency unknown - angioedema;
• From the respiratory system: very rarely - shortness of breath, cough, interstitial pneumonitis;
• From the skin: very rarely - increased sweating, feeling hot;
• From the digestive system: very often – nausea; very rarely - increased or decreased activity of liver enzymes in the blood (isolated), acute liver damage (sometimes fatal);
• Reactions at the injection site: often - pain, swelling, induration, erythema, necrosis, infiltration, extravasation, inflammation, phlebitis (including superficial), thrombophlebitis, cellulitis, pigmentation, infection.

special instructions

The drug should be taken only as prescribed by a doctor!

Side effects of Cordarone are dose-dependent, so treatment should be carried out in minimal effective doses.

During the period of use of the drug, patients should avoid exposure to direct sunlight.

The prescription of the drug should be made taking into account the data of an ECG and blood test to determine the potassium content. Correction of hypokalemia must occur before starting treatment. Treatment should be accompanied by regular monitoring of ECG (once every 3 months) and liver function indicators.

Patients with and without thyroid disease should undergo laboratory and clinical examinations of the thyroid gland before starting amiodarone therapy, during treatment, and for several months after discontinuation of the drug.

In case of suspicion functional disorders needs to be determined TSH level in blood serum.

During the period of use of the drug, patients should undergo X-ray examination of the lungs and pulmonary function tests every 6 months.

During long-term therapy of patients with a pacemaker or implanted defibrillator, it is necessary to regularly monitor their correct functioning.

When first degree AV block appears, it is necessary to intensify monitoring. In case of development of sinoatrial block, AV block of II and III degrees, or double-bundle intraventricular block, treatment should be discontinued.

Should be held ophthalmological examination with examination of the fundus of the eye when visual acuity decreases and blurred vision appears. In patients with optic neuritis or neuropathy that developed while taking amiodarone, further use of the drug should be discontinued.

Before the operation, you must inform the anesthesiologist about taking the drug.

Long-term therapy with Cordarone may increase the hemodynamic risk associated with anesthesia.

In addition, in rare cases, acute respiratory distress syndrome may occur in patients immediately after surgery, requiring careful monitoring during artificial ventilation.

IV jet administration should be carried out for at least 3 minutes, repeated administration is possible only 15 minutes after the first.

During the administration of the drug, the development of interstitial pneumonitis is possible, therefore, in the event of severe shortness of breath or a dry cough, with or without a deterioration in the general condition (fatigue, increased body temperature), the patient should undergo an x-ray chest. If the X-ray picture is abnormal, the drug must be discontinued, as the disease may develop pulmonary fibrosis.

Possible development of severe acute liver damage with the development of liver failure (sometimes fatal) during the first 24 hours injection use, it is necessary to regularly monitor liver function during therapy.

Concomitant use with verapamil, diltiazem and beta-blockers, except esmolol and sotalol, is only possible for the prevention of life-threatening ventricular arrhythmias and restoration of cardiac activity after cardiac arrest caused by ventricular fibrillation resistant to cardioversion.

drug interaction

Only the attending physician can determine the possibility of concomitant therapy, taking into account the condition and clinical indications of the patient.

Analogs

Analogs of Cordarone are: Amiocordin, Amiodarone, Amiodarone-SZ, Vero-Amiodarone, Cardiodarone, Ritmorest, Aritmil, Rotaritmil.

Terms and conditions of storage

Store out of the reach of children at temperatures up to 30 °C.

Shelf life – 3 years.

To normalize the heart rate, it is important to choose the most effective drug– in accordance with the spectrum of its effects and the nature of the arrhythmia. At the same time, it must be as safe as possible. In atrial fibrillation (AF), Cordarone occupies a wide niche of applicability.

Composition and release form

"Cordarone" is a drug called amiodarone hydrochloride. The product is produced in tablets (200 mg of amiodarone hydrochloride with a dividing line) and in solution for injection (3 ml ampoules containing 150 mg of amiodarone hydrochloride). The medicine is produced by Sanofi Winthrop Industry (France), Quinoin (Hungary).

Cordarone is a unique product of its kind

Cordarone is administered intravenously in emergency situations (during life-threatening arrhythmia attacks, in a hospital), with ECG and blood pressure (BP) monitoring, since there is a high risk of a critical drop in blood pressure and terminal heart failure. "Cordarone" is administered slowly, diluted with 5% glucose solution.

Pharmacological effects

"Cordarone" affects a number of factors affecting the reactivity and electrical conductivity of the sinoatrial and atrioventricular nerve nodes:

1. "Cordarone" is able to partially block potassium, sodium and calcium channels of cell membranes, it:

• slows down the passage of potassium and sodium ions through the myocardial membranes, lengthening the action potential and the effective refractory period, that is, the heartbeat becomes measured and calm;
• due to partial blockade of calcium transport, it expands peripheral vessels, reducing total peripheral resistance.

1. Reduces the sensitivity of heart adrenergic receptors to stress hormones.
2. Weakens the stimulating effect of thyroid hormones on the myocardium, inhibiting one of the links in their synthesis.

Since “Cordarone” affects many factors and little by little, it is relatively safe, as far as, in general, we can talk about the safety of use in relation to heart rate regulators.

In addition, Cordaron expands coronary vessels and reduces blood pressure

Who is Cordaron indicated for?

The choice is made in favor of “Cordaron” if:

• in a patient with arrhythmia, normal or decreased arterial pressure, and it cannot be further reduced;
• CHF is present and the contractility of the heart cannot be reduced;
• the patient does not have serious structural heart damage;
• The production of thyroid hormones is approximately within normal limits.

"Cordarone" is used for:

• stopping episodes of paroxysmal tachycardia, paroxysms and permanent forms of AF.
• prevention of repeated episodes of ventricular arrhythmias and fibrillations, attacks of AF, sudden, possibly fatal arrhythmias in post-infarction patients.

Contraindications

Cordarone is contraindicated for:

• dysfunction of the sinus node and atrioventricular (AV) block of the second and third degrees (without a pacemaker);
• hypokalemia, hypomagnesemia;
• diseases connective tissue lungs, non-cardiogenic pulmonary edema;
• the production of thyroid hormones is less than normal or above normal;
• prolongation of electrical systole on the ECG;

There are no medications without contraindications for their use. For “Kordaron” this is: periods of pregnancy and breastfeeding

• taking substances that prolong electrical systole and can provoke paroxysmal tachycardia, including pirouette-type tachycardia;
• childhood;
• pregnancy and breastfeeding;
• intolerance to iodine or amiodarone itself.

"Cordarone" is undesirable:

• with severe CHF;
• weakened liver function;
• respiratory failure and bronchial asthma;
• in old age;
• with AV block of the first degree.

Side effects

Side effects (tablets):

• moderate bradycardia (in 1–10% of cases);
• sinotrial or atrioventricular block (0.1–1%);
• provoking new arrhythmias or complicating existing ones either as a result of the action of the drug or due to its ineffectiveness - 0.1–1%;
• nausea, vomiting, reluctance to eat, heaviness in the stomach - 10% or more when taking saturating doses;
• increased liver transaminases and bile pigments, development of liver failure (1–10%);
• development chronic diseases liver – less than 0.01% of cases;
• pneumonitis and bronchiolitis obliterans (1–10%);
• bronchospasm, pulmonary edema (less than 0.01%);

Frequent adverse reactions when taking Cordarone: nausea and vomiting

• blurred vision caused by lipid deposits in the cornea (common), optic neuritis (very rare). In case of neuritis, the drug is immediately discontinued;
• hypothyroidism, hyperthyroidism (quite common);
• increased skin sensitivity to solar radiation (almost always);
• trembling of limbs, sleep disturbances.

Side effects of the injection solution:

• fever (“hot prick”), decreased blood pressure, bradycardia of varying severity;
• provoking arrhythmia (rare);
• increased levels of liver transaminases;
• anaphylactic shock, increased intracranial pressure, bronchospasm (extremely rare);
• phlebitis at the injection site.

Dosage of Cordarone for arrhythmia

At the beginning of taking Cordarone tablets in the hospital, the total (distributed) daily dose is prescribed from 600 to 1200 mg. The patient takes the drug in this amount for approximately a week until he consumes the “satiating” amount – 10 grams. Next, a maintenance dose of 100–400 mg per day is prescribed. The lowest dose possible to maintain the antiarrhythmic effect should be selected to avoid side effects.

Take Cordarone exactly as prescribed

At home, for safety reasons, the saturation period is extended to approximately 2 weeks, prescribing from 600 to 800 mg per day (in several doses). Upon reaching a saturating amount of 10 g, a maintenance dose is selected for the patient.

The maximum possible single dose is 400 mg. “Cordarone” is slowly released from the body, so regimens with a maintenance dose taken every other day are possible. The duration of maintenance therapy with Cordarone ranges from several months to 2 years.

Overdose

Acute overdose, symptoms:

• a sharp slowdown in heart rate;
• tachycardia, including the “pirouette” type;
• increased CHF;
• heart failure.

There is no specific antidote to Cordarone. If the drug has just been taken, it is necessary to rinse the stomach, give activated charcoal and call an ambulance; To relieve the effects of an overdose, administration of adrenaline or magnesium salts, or cardiac stimulation may be required.

How to take Cordarone during an attack of arrhythmia?

“Cordarone” is used to relieve an attack in the cardiology department or at least in the presence of an emergency doctor. It is dangerous to drink it on your own during an arrhythmia attack.

Cordarone in tablet form should be swallowed with water.

Interaction with other drugs

Cordarone should not be taken in parallel with:

• β-blockers, other antiarrhythmic drugs and calcium channel blockers (Verapamil, Diltiazem);
• antipsychotic medications (including Sultopride) and antidepressants (MAO inhibitors);
• "Pentamidine", "Vincamine", "Erythromycin".

It is not advisable to take Cordarone with laxatives and diuretics (possible potassium deficiency). If it is necessary to take anticoagulants, the level of prothrombin is monitored ( increased risk bleeding); cardiac glycosides – digoxin level (digoxin excretion decreases). List drug interactions incomplete, you must carefully study the instructions for the drug.

special instructions

During the Cordarona course:

• alcohol is contraindicated;
• exposure to the sun should be avoided. In addition to the possibility of burns, pigmentation acquires unnatural grayish shades;
• You should refrain from driving a car and activities that require high reaction speed.

Analogs of "Cordarone" - "Amiodarone", "Amiocordin", "Aritmil", "Cardiodarone", "Rotaritmil". "Cordarone" is sold by prescription. The price of tablets No. 30 is from 300 rubles or 200 hryvnia.

C.01.B.D.01 Amiodarone

Antiarrhythmic properties:

an increase in the duration of the 3rd phase of the action potential of cardiomyocytes, mainly due to blocking the ion current in potassium channels (the effect of a class III antiarrhythmic according to the Williams classification);

a decrease in the automaticity of the sinus node, leading to a decrease in heart rate;

non-competitive blockade of alpha and beta adrenergic receptors; slowing of sinoatrial, atrial and atrioventricular conduction, more pronounced with tachycardia; no changes in ventricular conductivity;

an increase in refractory periods and a decrease in the excitability of the myocardium of the atria and ventricles, as well as an increase in the refractory period of the atrioventricular node;

slowing down conduction and increasing the duration of the refractory period in additional atrioventricular conduction bundles.

Other effects:

lack of negative inotropic effect when taken orally; reduction of myocardial oxygen consumption due to a moderate decrease in peripheral resistance and heart rate; an increase in coronary blood flow due to a direct effect on the smooth muscle of the coronary arteries;

maintaining cardiac output by reducing aortic pressure and reducing peripheral resistance;

influence on the metabolism of thyroid hormones: inhibition of the conversion of T3 to T4

(blockade of thyroxine-5-deiodinase) and blocking the uptake of these hormones by cardiocytes and hepatocytes, leading to a weakening of the stimulating effect of thyroid hormones on the myocardium.

Therapeutic effects observed on average a week after starting to take the drug (from several days to two weeks). After stopping its use, it is determined in the blood plasma for 9 months. The possibility of maintaining the pharmacodynamic effect of amiodarone for 10-30 days after its discontinuation should be taken into account.

The antiarrhythmic drug is Cordarone. The instructions for use indicate that 200 mg tablets and injections in ampoules for intravenous injection have a coronary dilatator and antianginal effect. Reviews from patients and doctors confirm that this drug helps in the treatment of arrhythmia and atrial and ventricular fibrillation.

Release form and composition

Cordarone is available in the form:

• tablets for oral administration in blisters of 10 pieces, 3 blisters in a cardboard box with attached instructions. On one side of the tablet there is an engraving in the shape of a heart;
• solution for intravenous (i.v.) administration: transparent light yellow liquid (3 ml in ampoules, 6 pcs. in a box).

The main active ingredient of the drug is Amiodarone hydrochloride; 1 tablet contains 200 mg. The drug also contains a number of auxiliary components, including lactose monohydrate, which should be taken into account in patients with congenital lactose intolerance.

1 ml of solution contains 50 mg of active ingredient.

pharmachologic effect

In addition to the antiarrhythmic effect, Cordarone has coronary dilation, antianginal, as well as alpha and beta adrenergic blocking effects. The mechanism of the antiarrhythmic action of Cordarone is due to the ability of the drug to block the ion current in potassium channels and thereby increase the duration of the third phase of the action potential of cardiomyocytes.

Reduces heart rate by reducing the automatism of the sinus node, blocks alpha and beta adrenergic receptors, slows down atrial, sinoatrial and AV conduction, and also reduces the excitability of the myocardium of the atria and ventricles. The use of the drug allows you to achieve the desired effect within 7 days from the start of therapy. Sometimes this period takes from several days to two weeks.

Indications for use

What does Cordarone help with? Tablets are prescribed to prevent relapses:

• atrial fibrillation (atrial fibrillation) and atrial flutter;
• life-threatening ventricular arrhythmias and ventricular fibrillation (treatment should begin in the hospital with careful cardiac monitoring);
• documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients without organic heart disease, when antiarrhythmic drugs of other classes are not effective or there are contraindications to their use;
• supraventricular paroxysmal tachycardias, incl. documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients with organic heart diseases;
• documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients with WPW syndrome.

Prevention of sudden arrhythmic death in patients at high risk: patients after a recent myocardial infarction, with more than 10 ventricular extrasystoles per 1 hour, clinical manifestations of chronic heart failure and reduced left ventricular ejection fraction (<40%).

Solution

• relief of paroxysmal and stable forms of atrial fibrillation (atrial fibrillation) and atrial flutter;
• cardiac resuscitation for cardiac arrest caused by ventricular fibrillation resistant to cardioversion;
• relief of attacks of supraventricular paroxysmal tachycardia with a high frequency of ventricular contractions (especially against the background of WPW syndrome);
• relief of attacks of ventricular paroxysmal tachycardia.

Instructions for use

Cordarone tablets: orally, before meals, with a small amount of water. The dosage is prescribed by the doctor based on clinical indications and the patient’s condition. The loading dose in a hospital setting is increased, starting with a daily dose of 0.6-0.8 g (up to 1.2 g) divided into several doses, until a total dose of 10 g is reached after 5-8 days of administration; Outpatient saturation up to 10 g is carried out within 10-14 days at a daily dose of 0.6-0.8 g.

The maintenance dose should be the minimum effective, selected individually, and can range from 0.1 to 0.4 g per day. The average therapeutic single dose is 0.2 g, daily dose is 0.4 g. The maximum single dose is 0.4 g, daily dose is 1.2 g. Tablets can be taken every other day or with a break 2 days a week.

Injection: intended for intravenous administration to achieve a rapid antiarrhythmic effect or when it is impossible to take the drug orally. In addition to special emergency clinical situations, the solution should be used only in intensive care hospital conditions under constant monitoring of blood pressure and electrocardiogram (ECG).

The solution should not be mixed with other agents, administered into the same infusion line, or used undiluted. For dilution, it is necessary to use only a 5% dextrose (glucose) solution; the concentration of the resulting solution should be no less than when diluting 6 ml of the drug in 500 ml of 5% dextrose (glucose).

Administration should always be done through a central venous catheter; administration through peripheral veins is allowed for cardiac resuscitation in ventricular fibrillation resistant to cardioversion in the absence of central venous access.

In case of severe cardiac arrhythmias, if it is impossible to take the drug orally, intravenous drip administration through a central venous catheter is recommended at the usual loading dose at the rate of 0.005 g per 1 kg of patient weight in 250 ml of a 5% dextrose (glucose) solution. It should be administered over 20-120 minutes, preferably using an electronic pump. It can be administered 2-3 times within 24 hours; adjustment of the rate of administration depends on the clinical effect.

The maintenance daily dose of amiodarone is usually prescribed in the amount of 0.6-0.8 g, which can be increased to 1.2 g in 250 ml of a 5% dextrose (glucose) solution. Over the course of 2-3 days of intravenous administration, you should gradually switch to taking the drug orally.

Intravenous jet administration during cardiac resuscitation during cardiac arrest due to ventricular fibrillation, resistant to cardioversion, is recommended at a dose of 0.3 g of the drug diluted in 20 ml of a 5% dextrose (glucose) solution. If there is no clinical effect, additional administration of 0.15 g of amiodarone is possible.

Contraindications

This medicine can be used by patients only as prescribed by a doctor after a thorough examination. Before starting therapy, it is recommended to carefully study the accompanying instructions for restrictions. Contraindications to the use of the drug Cordarone are:

• Sinus bradycardia;
• Congenital lactose intolerance or lactase deficiency;
• Interstitial lung disease;
• Age up to 18 years;
• Simultaneous use of drugs that change electrocardiogram parameters and can cause the development of paroxysmal tachycardias;
• Pregnancy and breastfeeding period;
• Individual intolerance to the components of the drug;
• Severe thyroid dysfunction (hyper or hypothyroidism);
• Hypokalemia or hypomagnesemia.

With particular caution, the drug can be used in patients with chronic heart failure in the stage of decompensation, liver or kidney failure, bronchial asthma, respiratory failure, as well as elderly people (over 65 years).

Side effects

Cordarone can cause the following side effects: alopecia, decreased potency, myopathy, vasculitis, epididymitis, photosensitivity, skin pigmentation, increased sweating.

Long-term use causes aplastic anemia, hemolytic anemia, thrombocytopenia, allergic reactions, dermatitis. When administered parenterally, phlebitis develops.

• Respiratory system: apnea, bronchospasm, pleurisy, pulmonary fibrosis, alveolitis, interstitial pneumonia, shortness of breath, cough.
• Sense organs: retinal microdetachment, lipofuscin deposition in the corneal epithelium, uveitis.
• Cardiovascular system: drop in blood pressure, tachycardia, progression of CHF, atrioventricular block, sinus bradycardia. Metabolism: thyrotoxicosis, hypothyroidism, increased T4 levels.
• Digestive system: liver cirrhosis, jaundice, cholestasis, toxic hepatitis, increased levels of liver enzymes, loss, dulling of taste perception, decreased appetite, vomiting, nausea.
• Nervous system: sleep disturbances, memory disturbances, peripheral neuropathy, paresthesia, auditory hallucinations, fatigue, depression, dizziness, weakness, headaches, optic neuritis, intracranial hypertension, ataxia, extrapyramidal manifestations.

Children, pregnancy and breastfeeding

Cordarone is contraindicated during pregnancy and lactation (breastfeeding).

Amiodarone is excreted in breast milk in significant quantities, so if it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Contraindicated in children and adolescents under 18 years of age (efficacy and safety have not been established).

special instructions

Before starting therapy, an ECG study and a blood test for potassium content should be performed. Hypokalemia must be corrected before starting the drug. Every 3 months during treatment you need to undergo an ECG, monitor transaminase activity and other indicators of liver function.

Patients with a history of thyroid disease should be examined before starting treatment to identify dysfunctions and diseases of the thyroid gland. During therapy with Cordarone, X-ray examination of the lungs and pulmonary function tests should be performed every six months.

If AV blockade of the second and third degrees, sinoatrial block or double-bundle intraventricular block develops, Cordarone should be discontinued. Long-term use of the drug may increase hemodynamic risk when local or general anesthesia is administered.

drug interaction

Arterial hypotension, bradycardia, and conduction disturbances can develop during oxygen therapy and during general anesthesia using drugs for inhalation anesthesia.

Cordarone causes an increase in the level of procainamide, phenytoin, quinidine, digoxin, cyclosporine, flecainide in the blood plasma.

Drugs that cause photosensitivity may cause additive photosensitizing effects.

With the simultaneous use of lithium drugs, the risk of hypothyroidism increases. Cimetidine increases the half-life of the main component, and cholestyramine reduces its absorption in the blood plasma.

“Loop” diuretics, astemizole, tricyclic antidepressants, phenothiazines, terfenadine, thiazides, sotalol, glucocorticosteroids, laxatives, pentamidine, tetracosactide, first class antiarrhythmic drugs, amphotericin B can provoke an arrhythmogenic effect.

Cordarone is able to inhibit the absorption of sodium pertechnett, sodium iodide, by the thyroid gland. The drug causes increased effects of indirect anticoagulants (acenocoumarol and warfarin).

Cardiac glycosides, Verapamil, beta-blockers increase the likelihood of inhibition of atrioventricular conduction and the development of bradycardia. When prescribing warfarin, its dosage is reduced to 66%, when prescribing acenocoumarol - by 50%, monitoring of prothrombin time is mandatory.

Analogues of the drug Cordarone

Analogues are determined by structure:

1. Amiodarone.
2. Amiocordin.
3. Vero Amiodarone.
4. Cardiodarone.
5. Opacordan.
6. Rhythmiodarone.
7. Sedakoron.

Antiarrhythmic drugs include:

1. Cardiodarone.
2. Ritalmex.
3. Neo Gilurithmal.
4. Sedakoron.
5. Bretylate.
6. Rhythmonorm.
7. Rhythmodan.
8. Allapinin.
9. Hypertonplant (Gnafalin).
205

DOSAGE FORM, COMPOSITION AND PACKAGING

Tablets are round, divisible, white or off-white in color, engraved with a symbol in the form of a center and the number “200” on one side; tablets can be easily separated along the break line under normal conditions of use.

1 tab.
amiodarone hydrochloride 200 mg

Excipients: lactose monohydrate, corn starch, polyvidone K90F, colloidal anhydrous silicon dioxide, magnesium stearate.

10 pieces. - blisters (3) - cardboard packs.

PHARMACHOLOGIC EFFECT

Class III antiarrhythmic drug. Has antiarrhythmic and antianginal effects.

The antiarrhythmic effect is due to an increase in phase 3 of the action potential, mainly due to a decrease in potassium current through the channels of the cell membranes of cardiomyocytes and a decrease in the automaticity of the sinus node. The drug non-competitively blocks α- and β-adrenergic receptors. Slows down sinoatrial, atrial and nodal conduction without affecting intraventricular conduction. Cordarone increases the refractory period and reduces myocardial excitability. Slows down the conduction of excitation and lengthens the refractory period of additional atrioventricular pathways.

The antianginal effect of Cordarone is due to a decrease in oxygen consumption by the myocardium (due to a decrease in heart rate and a decrease in peripheral resistance), non-competitive blockade of α- and β-adrenergic receptors, an increase in coronary blood flow through a direct effect on the smooth muscles of the arteries, maintaining cardiac output by reducing pressure in the aorta and reducing peripheral resistance .

Cordarone does not have a significant negative inotropic effect and reduces myocardial contractility mainly after intravenous administration.

It affects the exchange of thyroid hormones, inhibits the conversion of T3 to T4 (blockade of thyroxine-5-deiodinase) and blocks the uptake of these hormones by cardiocytes and hepatocytes, which leads to a weakening of the stimulating effect of thyroid hormones on the myocardium. Determined in blood plasma for 9 months after stopping its use.

Therapeutic effects are observed 1 week (from several days to 2 weeks) after starting to take the drug orally.

With intravenous administration of Cordarone, its activity reaches a maximum after 15 minutes and disappears approximately 4 hours after administration. Despite the fact that the amount of administered Cordarone in the blood quickly decreases, tissue saturation with the drug is achieved. In the absence of repeated injections, the drug is gradually eliminated. When its administration is resumed or when the drug is prescribed for oral administration, its tissue reserve is formed.

PHARMACOKINETICS

Suction

After oral administration, amiodarone is absorbed slowly (absorption is 30-50%), the rate of absorption is subject to significant fluctuations. Bioavailability after oral administration ranges from 30 to 80% in different patients (on average about 50%). After a single dose of the drug orally, Cmax in blood plasma is achieved within 3-7 hours.

Distribution

Amiodarone has a large Vd. Amiodarone accumulates most in adipose tissue, liver, lungs, spleen and cornea. After a few days, amiodarone is eliminated from the body. Css is achieved within 1 to several months, depending on the individual characteristics of the patient. Binding to blood plasma proteins is 95% (62% to albumin, 33.5% to beta-lipoproteins).

Metabolism

Metabolized in the liver. The main metabolite, desethylamiodarone, is pharmacologically active and can enhance the antiarrhythmic effect of the main compound. Each dose of Cordarone (200 mg) contains 75 mg of iodine; 6 mg of this was determined to be released as free iodine. With prolonged treatment, its concentrations can reach 60-80% of amiodarone concentrations.

Removal

Elimination when taken orally occurs in 2 phases: T1/2 in the α-phase - 4-21 hours, T1/2 in the β-phase - 25-110 days. After prolonged oral administration, the average T1/2 is 40 days (this is important when choosing a dose, since at least 1 month is required to stabilize the plasma concentration, and complete elimination can last more than 4 months).

After discontinuation of the drug, its complete elimination from the body continues for several months. The presence of pharmacodynamic effects of Cordarone should be taken into account for 10 days and up to 1 month after its discontinuation. Amiodarone is excreted in bile and feces. Renal excretion is negligible.

Pharmacokinetics in special clinical situations

Insignificant excretion of the drug in the urine allows the drug to be prescribed in moderate doses for renal failure. Amiodarone and its metabolites are not dialyzable.

INDICATIONS

Relief of attacks of ventricular paroxysmal tachycardia;

Relief of attacks of supraventricular paroxysmal tachycardia with a high frequency of ventricular contractions (especially against the background of WPW syndrome);

Relief of paroxysmal and persistent forms of atrial fibrillation (atrial fibrillation) and atrial flutter.

Relapse Prevention

Life-threatening ventricular arrhythmias and ventricular fibrillation (treatment should be started in a hospital with careful cardiac monitoring);

Supraventricular paroxysmal tachycardias, incl. documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients with organic heart diseases; documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients without organic heart disease, when antiarrhythmic drugs of other classes are not effective or there are contraindications to their use; documented attacks of recurrent sustained supraventricular paroxysmal tachycardia in patients with WPW syndrome;

Atrial fibrillation (atrial fibrillation) and atrial flutter.

Prevention of sudden arrhythmic death in high-risk patients after a recent myocardial infarction, with more than 10 ventricular extrasystoles per hour, clinical manifestations of chronic heart failure and reduced left ventricular ejection fraction (Cordarone is especially recommended for patients with organic heart disease (including . with ischemic heart disease), accompanied by left ventricular dysfunction.

Cordarone for intravenous administration is intended only for use in a hospital in cases where rapid achievement of an antiarrhythmic effect is required or when it is impossible to take the drug orally.

DOSING REGIME

For oral administration

When prescribing the drug in a loading dose, various schemes can be used. When used in a hospital, the initial dose, divided into several doses, ranges from 600-800 mg/day to a maximum of 1200 mg/day (usually for 5-8 days).

For outpatient use, the initial dose, divided into several doses, ranges from 600 mg to 800 mg / day (usually for 10-14 days).

The maintenance dose is determined at the rate of 3 mg/kg body weight per day and can range from 100 mg/day to 400 mg/day when taken once a day. The minimum effective dose should be used. Because Amiodarone has a very long half-life, the drug can be taken every second day (200 mg can be given every second day, and 100 mg is recommended to be taken daily) or taken in breaks (2 days a week).

For solution for intravenous administration

The loading dose of Cordarone is initially 5-7 mg/kg body weight in 250 ml of a 5% dextrose (glucose) solution for 30-60 minutes. The therapeutic effect of Cordarone appears during the first minutes of administration and disappears gradually, which requires adjustment of the rate of its administration in accordance with the results of treatment.

For maintenance therapy, the drug is prescribed as a continuous or intermittent (2-3 times/day) intravenous infusion in a 5% dextrose (glucose) solution for several days at a dose of up to 1200 mg/day. After IV administration in a loading dose, instead of continuing the IV infusion, it is possible to switch to taking Cordarone orally at a dose of 600-800 mg to 1200 mg/day. From the first day of intravenous administration of Cordarone, it is advisable to begin a gradual transition to taking the drug orally.

When performing intravenous injections, the drug at a dose of 5 mg/kg is administered over at least 3 minutes. Cordarone cannot be taken into the same syringe with other medications!

For intravenous infusion, concentrations below 600 mg/l should not be used. To prepare solutions for intravenous administration, use only a 5% dextrose (glucose) solution.

SIDE EFFECT

Solution for intravenous administration

Systemic reactions: feeling of heat, increased sweating, decreased blood pressure (usually moderate and transient); cases of severe arterial hypotension or collapse (have been reported with overdose or too rapid administration), moderate bradycardia (in some cases, especially in elderly patients, severe bradycardia and, in exceptional cases, sinus node arrest, requiring discontinuation of therapy); rarely - proarrhythmic effect. At the beginning of therapy, there is an increase in the activity of hepatic transaminases in the blood serum, which usually remains moderate (1.5-3 times higher than the upper limit of normal (ULN)) and, as a rule, normalizes when the dose is reduced or even spontaneously. If transaminase levels increase significantly, treatment should be discontinued. There are isolated case reports of acute liver failure with high serum levels of liver transaminases and/or jaundice (some with fatal outcome). In isolated (exceptionally rare) cases, anaphylactic shock, benign intracranial hypertension (pseudotumor of the brain), bronchospasm and/or apnea were observed in patients with severe respiratory failure, especially in patients with bronchial asthma. Several cases of acute respiratory distress, mostly associated with interstitial pneumonitis, have been observed.

Local reactions: phlebitis (can be avoided by using a central venous catheter).

For oral administration

From the cardiovascular system: bradycardia (mostly moderate and dose-dependent); in some cases (with sinus node dysfunction, in the elderly) - severe bradycardia; in exceptional cases - sinus block; rarely - conduction disorders (sinoatrial block, AV block of various degrees, intraventricular block); in some cases - the emergence of new arrhythmias or aggravation of existing ones, in some cases - with subsequent cardiac arrest (according to available data, it is impossible to establish a connection with the use of the drug, with the severity of heart damage or with the ineffectiveness of treatment). These effects are observed mainly in cases of combined use of Cordarone with drugs that prolong the period of repolarization of the ventricles of the heart (QTc interval) or in case of electrolyte imbalance.

On the part of the organ of vision: microdeposits of lipofuscin in the cornea of ​​the eye (almost always present) are usually limited to the pupil area, are reversible after discontinuation of the drug, sometimes lead to visual impairment in the form of the appearance of a colored halo in bright light or a feeling of fog; in some cases - neuropathy/optic neuritis (the connection with amiodarone has not been clearly established to date).

Dermatological reactions: photosensitivity; erythema (during radiotherapy); in some cases - rash (usually nonspecific), exfoliative dermatitis (the connection with taking the drug has not been formally established); with prolonged use in high doses - grayish or bluish pigmentation of the skin (slowly disappears after stopping treatment).

From the endocrine system: an increase in the level of T3 in the blood serum (T4 remains normal or slightly reduced) in such cases, in the absence of clinical signs of thyroid dysfunction, discontinuation of the drug is not required); possible development of hypothyroidism (mild weight gain, decreased activity, more pronounced (compared to expected) bradycardia); hyperthyroidism (both during therapy and for several months after stopping the drug). Suspicion of hyperthyroidism may arise from the following mild clinical symptoms: weight loss, development of arrhythmia, angina pectoris, heart failure. The diagnosis is confirmed by a clear decrease in serum TSH. Amiodarone should be discontinued.

From the digestive system: nausea, vomiting, taste disturbances (usually found at the beginning of therapy when used in loading doses and decrease when the dose is reduced); at the beginning of treatment - an isolated increase (1.5-3 times higher than ULN) in the activity of liver transaminases (they decrease with a decrease in the dose of the drug or even spontaneously); in some cases - acute liver dysfunction and/or jaundice (require discontinuation of the drug), fatty hepatosis, cirrhosis. Clinical symptoms and laboratory changes may be minimal (hepatomegaly is possible, increased activity of liver transaminases is increased to 1.5-5 times compared to ULN); Therefore, regular monitoring of liver function is recommended during treatment.

From the respiratory system: in some cases - pneumonitis, fibrosis, pleurisy, bronchiolitis obliterans with pneumonia (sometimes resulting in death), bronchospasm in patients with severe respiratory diseases (especially bronchial asthma), acute respiratory distress syndrome in adults.

From the central nervous system and peripheral nervous system: rarely - sensorimotor peripheral neuropathies and/or myopathies (usually reversible after discontinuation of the drug), extrapyramidal tremor, cerebellar ataxia; in rare cases - benign intracranial hypertension, nightmares.

Allergic reactions: rarely - vasculitis, kidney damage with increased creatinine levels, thrombocytopenia; in some cases - hemolytic anemia, aplastic anemia.

Other: alopecia; in some cases - epididymitis, impotence (no connection with the use of the drug has been established).

CONTRAINDICATIONS

For oral administration

SSS (sinus bradycardia, sinoatrial block) except in cases of correction with an artificial pacemaker;

AV and intraventricular conduction disorders (2nd and 3rd degree AV block, bundle branch block) in the absence of an artificial pacemaker (pacemaker);

Thyroid dysfunction (hypothyroidism, hyperthyroidism);

Hypokalemia;

Heart failure (in the stage of decompensation);

Concomitant use of MAO inhibitors;

Interstitial lung diseases;

Pregnancy;

Lactation;

For solution for intravenous administration

SSS (sinus bradycardia, sinoatrial block) with the exception of patients with an artificial pacemaker (danger of sinus node arrest);

AV blockade of II and III degrees, intraventricular conduction disorders (blockade of two and three branches of the His bundle); in these cases, IV amiodarone can be used in specialized departments under the cover of an artificial pacemaker (pacemaker);

Acute cardiovascular failure (shock, collapse);

Severe arterial hypotension;

Simultaneous use with drugs that can cause polymorphic ventricular tachycardia of the “pirouette” type;

Thyroid dysfunction (hypothyroidism, hyperthyroidism);

Pregnancy;

Lactation;

Age up to 18 years (efficacy and safety have not been established);

Hypersensitivity to iodine and/or amiodarone.

IV administration is contraindicated in severe pulmonary dysfunction (interstitial lung disease), cardiomyopathy or decompensated heart failure (possible deterioration of the patient's condition).

Use with caution in chronic heart failure, liver failure, bronchial asthma, and in old age (due to the high risk of developing severe bradycardia).

PREGNANCY AND LACTATION

During pregnancy, Cordarone is prescribed only for health reasons, because the drug has an effect on the fetal thyroid gland.

Amiodarone is excreted in breast milk in significant quantities, so the drug is contraindicated for use during lactation.

SPECIAL INSTRUCTIONS

Before starting and during treatment, it is recommended to conduct an ECG study. Due to the prolongation of the period of repolarization of the ventricles of the heart, the pharmacological action of Cordarone causes certain changes in the ECG: prolongation of the QT interval, QTc, the appearance of U waves is possible. An increase in the QTc interval is permissible by no more than 450 ms or by no more than 25% of the original value. These changes are not a manifestation of the toxic effect of the drug, but require monitoring to adjust the dose and assess the possible proarrhythmogenic effect of Cordarone.

It should be taken into account that in elderly patients there is a more pronounced decrease in heart rate.

If second or third degree AV block, sinoatrial or bifascicular block develops, treatment with Cordarone should be discontinued.

The appearance of shortness of breath or nonproductive cough may be associated with the toxic effect of Cordarone on the lungs. In patients with increasing shortness of breath during exercise, regardless of the deterioration of their general condition (increased fatigue, weight loss, increased body temperature), a chest x-ray should be performed before starting therapy. Respiratory problems are mostly reversible with early discontinuation of amiodarone. Clinical symptoms usually resolve within 3-4 weeks, followed by a slower recovery of radiographic appearance and pulmonary function (several months). Therefore, the possibility of re-evaluating amiodarone therapy and prescribing corticosteroids should be considered.

If blurred vision or decreased visual acuity occurs while taking Cordarone, it is recommended to conduct a full ophthalmological examination, including fundoscopy. Cases of optic neuropathy and/or optic neuritis require a decision on the advisability of using Cordarone.

Cordarone contains iodine (200 mg contains 75 mg of iodine), so it may affect the results of tests for the accumulation of radioactive iodine in the thyroid gland, but does not affect the reliability of the determination of T3, T4 and TSH. Amiodarone may cause thyroid dysfunction, especially in patients with a history of thyroid dysfunction (including a family history). Therefore, before starting treatment, during treatment and several months after the end of treatment, careful clinical and laboratory monitoring should be carried out. If thyroid dysfunction is suspected, serum TSH levels should be measured. When signs of hypothyroidism appear, normalization of thyroid function is usually observed within 1-3 months after cessation of treatment. In life-threatening situations, treatment with amiodarone can be continued, with simultaneous additional administration of levothyroxine. Serum TSH levels serve as a guide for levothyroxine dosage. If signs of hyperthyroidism appear, amiodarone should be discontinued. Normalization of thyroid function usually occurs within several months after discontinuation of the drug. In this case, clinical symptoms normalize before normalization of the level of hormones that reflect the function of the thyroid gland occurs. In severe cases, immediate medical intervention is required. Treatment in each individual case is selected individually and includes antithyroid drugs (which may not always be effective), corticosteroids, and beta-blockers.

Cordarone for intravenous administration is used only in a specialized hospital department under constant monitoring of ECG and blood pressure. In this case, Cordarone should be administered by infusion rather than by injection due to the risk of hemodynamic disturbances (hypotension, acute cardiovascular failure).

IV injections of Cordarone should be performed only in emergency situations, when there are no other therapeutic options, and only in cardiac intensive care units with continuous ECG monitoring.

When administering Cordarone by injection, a dose of approximately 5 mg/kg should be administered over at least 3 minutes. The injection should not be repeated earlier than 15 minutes after the first injection, even if the last one consisted of only one ampoule (irreversible collapse is possible).

Particular caution is required when infusing the drug in cases of arterial hypotension, severe respiratory failure, decompensated cardiomyopathy or severe heart failure.

Patients should avoid prolonged exposure to the sun and UV radiation (or use sunscreen).

Influence on the ability to drive vehicles and control mechanisms

Currently, there is no evidence that Cordarone affects the ability to drive vehicles and operate machinery.

OVERDOSE

Symptoms: sinus bradycardia, cardiac arrest, ventricular tachycardia, paroxysmal ventricular tachyarrhythmias of the “pirouette” type, circulatory disorders, liver dysfunction, decreased blood pressure.

Treatment: symptomatic therapy is carried out (gastric lavage, administration of cholestyramine, for bradycardia - beta-adrenergic stimulants or installation of a pacemaker, for tachycardia of the "pirouette" type - intravenous administration of magnesium salts, reducing pacemaker). Amiodarone and its metabolites are not removed by dialysis.

There is no information about overdose with intravenous administration of Cordarone.

DRUG INTERACTIONS

When taking Cordarone simultaneously with antiarrhythmic drugs (including bepridil, class I A drugs, sotalol), as well as with vincamine, sultopride, erythromycin for intravenous administration, pentamidine for parenteral administration, the risk of developing polymorphic paroxysmal ventricular tachycardia of the “pirouette” type increases. Therefore, these combinations are contraindicated.

Combination therapy with beta-blockers and some calcium channel blockers (verapamil, diltiazem) is not recommended, because Automaticity disorders (manifested by bradycardia) and conduction may develop.

It is not recommended to use Cordarone simultaneously with laxatives (stimulating intestinal motility), which can cause hypokalemia, because the risk of developing ventricular tachycardia of the “pirouette” type increases.

Cordarone should be used with caution simultaneously with drugs that cause hypokalemia (diuretics, systemic corticosteroids and mineralocorticoids, tetracosactide, amphotericin B /for intravenous administration/), because the development of ventricular tachycardia of the “pirouette” type is possible.

When Cordarone is used simultaneously with anticoagulants for oral administration, the risk of bleeding increases (therefore, it is necessary to monitor the level of prothrombin and adjust the dose of anticoagulants).

With the simultaneous use of Cordarone with cardiac glycosides, disturbances in automaticity (manifested by severe bradycardia) and disturbances in atrioventricular conduction may be observed. In addition, it is possible to increase the concentration of digoxin in the blood plasma due to a decrease in its clearance (therefore, it is necessary to monitor the concentration of digoxin in the blood plasma, conduct an ECG and laboratory monitoring, and, if necessary, change the dosage regimen of cardiac glycosides).

With the simultaneous use of Cordarone with phenytoin, cyclosporine, flecainide, it is possible to increase the concentration of the latter in the blood plasma (therefore, the concentration of phenytoin, cyclosporine, flecainide in the blood plasma should be monitored and their dose adjusted if necessary).

Cases of bradycardia (resistant to atropine), arterial hypotension, conduction disturbances, and decreased cardiac output have been described in patients taking Cordarone and undergoing general anesthesia.

When using oxygen therapy in the postoperative period in patients receiving Cordarone, rare cases of severe respiratory complications, sometimes resulting in death (acute adult respiratory distress syndrome), have been described.

When used together with simvastatin, the risk of side effects (primarily rhabdomyolysis) may increase due to disruption of the metabolism of simvastatin (if it is necessary to use such a combination, the dose of simvastatin should not exceed 20 mg/day; if the therapeutic effect is not achieved at this dose, you should switch to another lipid-lowering drug).

CONDITIONS OF VACATION FROM PHARMACIES
The drug is dispensed by prescription. The drug in the form of a solution for intravenous administration is intended for use only in a hospital setting.

CONDITIONS AND DURATION OF STORAGE

The drug in tablet form should be stored at room temperature (not higher than 30°C). The shelf life of the tablets is 3 years. The drug in the form of a solution for intravenous administration should be stored in a dry place at a temperature not exceeding 25°C. The shelf life of the solution for intravenous administration is 2 years.